Allogenic NK Cell Transfusion Azacitidine MDS-EB

MDS-EB Clinical Trial

Official title:

Safety and Efficacy of Allogenic NK Cell Transfusion Combined With Azacitidine Therapy for the MDS-EB

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04599426
• Other study ID #: 2020.NK.MDS-EB
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2020
• Source: The Second Hospital of Shandong University
• Contact: Chengyun Zheng, Ph.D.
• Phone: +86-531-85875502
• Email: chengyun.zheng[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this investigation was to assess safety and efficacy of allogenic NK cells therapy for refractory MDS-EB.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Patients with refractory high-risk MDS (MDS-EB1 and EB2) who had no effect of 2 courses of desitabine or CAG or desitabine + CAG.

2. Patients with age 15 years to 70 years.

3. KPS greater than or equal to 60.

4. ALT and AST are less than 3 times normal.

5. Total bilirubin less than 1.5mg/dl(25.65umol/L).

6. Serum creatinine less than 2.5mg/dl(221umol/L), or creatinine scavenging ability greater than or equal to 60 mL/min/1.73 m2.

7. Left ventricular ejection fraction cardiac greater than or equal to 45%, Echocardiography (ECHO) showed no pericardial effusion, Electrocardiogram (ECG) is normal.

8. No pleural effusion in lungs.

9. Oxyhemoglobin saturation greater than or equal to 92% in normal environment.

10. Women of child-bearing age have negative urine pregnancy tests before administration began, and agree to use effective contraception during the trial period up to the last follow-up.

11. KIR mismatch between patient and umbilical cord blood.

12. Volunteer to participate in the trial and sign the informed consent form.

Exclusion Criteria:

1. Malignant tumor patient.

2. Patients who are accompanied by fungal, bacterial, viral, or other uncontrolled infections or require level 4 isolation. (HBV-DNA quantification and normal liver function in patients with hepatitis b infection are excluded).

3. Patients with HIV, HCV positive.

4. Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.

5. Patients with central nervous system diseases, including stroke, epilepsy, dementia, or autoimmune central nervous system disorders.

6. Patients receiving anticoagulant therapy or with severe coagulation disorders.

7. According to the researcher's judgment, the drug treatment the patient is receiving will affect the safety and effectiveness of the study.

8. Patients with allergies or history of allergies to biological agents used in this program.

9. Lactating or pregnant women.

10. Systemic steroid used within 2 weeks before treatment (except for recent or present use of inhaled corticosteroids).

11. Patients with other uncontrolled diseases, Investigators think it is not suitable for the participants.

12. Any circumstance that the investigator considers may increase the risk to the subject or interfere with the results of the study.

13. Patients participate in other clinical studies.

Related Conditions & MeSH terms

• Anemia, Refractory, with Excess of Blasts
• MDS-EB

Intervention

Biological:
• Allogeneic NK cell regimen group
10 patients with refractory MDS-RAEB were treated with allogeneic NK cell regimen. Allogeneic NK cell regimen ×3 cycle; Cyclophosphamide 300mg/m2.d d1to 3; G-CSF 150ug bid d4-11; Azacitidine 75mg/m2 d5-11; Allogeneic NK cell 10-30×10^6/kg d13,d15 .

Locations

Country	Name	City	State
China	The 2nd Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) (PR+CR)	The proportion of patients with complete response(CR) or partial response(PR) as measured by International Working Group efficacy Criteria for myelodysplastic syndromes	3 months
Secondary	Overall survival(OS)	The proportion of patients with overall survival(OS).	1 year